- How is this information different than what’s available from Emergo by UL?
RAMS includes regulatory process charts that weren’t available before on new markets that medical device companies might want to explore. Consolidating them all into one location makes it easier for customers to locate.
- Is RAMS free?
Yes, it's free to register for RAMS. Some premium services, such as Registration Tracker, Regulatory Updates, and Regulatory Intelligence available for a free 30-day trial. Log in for details.
- What is the difference between RAMS-Track and RAMS?
RAMS-Track was a single tool to track your medical device regulatory approvals. RAMS still includes that along with more tools such as the FDA 510(k) calculator, regulatory process overviews, and more.
- If I previously signed up for a free trial, can I reactivate my account?
Yes. If your 30-day free trial has expired, you will need to renew your account.
- How are regulatory alerts different in RAMS?
We added more historical data from our global team of regulatory experts to include more insights into market data. In addition to alerts regarding your medical device registrations, RAMS provides weekly notifications about regulatory news from around the world.
You can filter these notifications or flag items to track a topic you want to follow. RAMS is a robust source of information that will keep you informed about changes that could impact your medical device business.
- Why is registration tracking important?
Medical device manufacturers are responsible for maintaining and renewing their medical device registrations in all countries where they are approved for sale. For many manufacturers, this means tracking hundreds, if not thousands, of registrations. Failing to renew a registration before its expiration date has serious consequences, including restrictions on sales and more difficult regulatory requirements.
Managing large amounts of data about your medical device registrations can be difficult and time-consuming. We’ve also found that the ways in which companies handle this information varies considerably – from manually editing spreadsheets to writing down registration details on paper notes.
RAMS aims to make this task easier and more manageable so Regulatory Affairs specialists can minimize the risk of expired medical device registrations.
- Different countries have different re-registration times, so how does RAMS know when to alert me about a registration that is expiring soon?
A registration is considered Expiring Soon when it enters the ideal time period to initiate renewal activities. The date in which a registration enters the Expiring Soon stage can be set for each country in which you have registrations. RAMS enables you to adjust the default alert dates for each country and create custom alert dates for individual registrations.
- Can my teammates access RAMS?
Yes, you can add as many teammates to your RAMS account as you wish. You can also control their access to view and modify registrations. You can even create accounts for your distributors and allow them to only view registrations for the products they distribute.
- Does RAMS keep track of edits to registration details?
Yes, RAMS maintains audit trails of all registration modifications made by any member of your team.
- Can I export my data from RAMS?
Yes, you can export all your registration to an Excel spreadsheet or to a PDF report.
- Our registration data is sensitive. Will RAMS keep it secure?
Yes, RAMS conforms to industry best practices for security. If you would like additional details about our security procedures and policies, please contact us.
- Can RAMS help me prepare a submission for FDA clearance?
RAMS offers functionality to complete forms for clearance using the groundbreaking 510(k) Builder software. Currently this subscription-based system offers support for US FDA 510(k) clearance.
- How is creating my document for submission through RAMS better than the traditional way?
Smart Builder guides you through FDA 510(k) submission, MDD, and MDR documentation step-by-step with a Keyword system that can facilitate consistent use of key textual components such as the product and indications for use throughout the application. Commenting facilitates collaboration among team members. Automated formatting also greatly reduces the time required to produce a complete, professional submission. RAMS Smart Builder MDD and MDR tools help you comply with MDD 93/42/EEC, MEDDEV 2.7/1, and the upcoming MDR 2017/745.
- What if I need support completing the FDA 510(k), MDD or MDR documents?
Consulting support is available to answer questions and help you resolve the difficulties with your documentation.
RAMS Top FAQs
Get answers about registering, renewing accounts and what tools you’ll find in RAMS.